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Divarasib vs Other Treatments for Lung Cancer (Krascendo 1 Trial)
Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documentation of the presence of a KRAS G12C mutation
Disease progression during or after treatment with at least one prior systemic therapy but no more than three lines of prior systemic therapy in the metastatic setting
Must not have
Malabsorption syndrome or other condition that would interfere with enteral absorption
Uncontrolled tumor-related pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to determine if divarasib is safe and effective in treating advanced or metastatic non-small cell lung cancer with a specific genetic mutation (KRAS G12C) compared to other approved
Who is the study for?
This trial is for people with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific mutation known as KRAS G12C. Participants should have previously been treated for their condition.
What is being tested?
The study is testing the effectiveness and safety of a new drug called Divarasib compared to already approved drugs, Sotorasib or Adagrasib, in patients with the KRAS G12C mutation in NSCLC.
What are the potential side effects?
Potential side effects may include typical reactions seen with cancer treatments such as nausea, fatigue, liver enzyme changes, and possibly unique effects related to Divarasib which are being studied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has a KRAS G12C mutation.
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My cancer has worsened despite 1-3 treatments.
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I can provide a specific type of tumor sample for testing.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My lung cancer is at an advanced stage and cannot be removed by surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have conditions that affect how my body absorbs food.
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I have pain from my cancer that isn't relieved by treatment.
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My cancer has spread to the lining of my brain and spinal cord.
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I have not been treated with KRAS G12C or pan-KRAS/RAS inhibitors.
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I have received over 30 Gy of lung radiotherapy in the last 6 months.
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I still have side effects from previous cancer treatments.
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My cancer has a known secondary genetic mutation.
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My lung cancer is of a specific type (small-cell or large cell neuroendocrine).
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I have untreated or active brain metastases.
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I frequently need procedures to remove excess fluid from my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-Free Survival (PFS)
Secondary study objectives
Duration of Response (DOR)
Objective Response
Overall Survival (OS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DivarasibExperimental Treatment1 Intervention
Participants will receive divarasib orally, once daily (QD).
Group II: KRAS G12C inhibitorActive Control2 Interventions
Participants will receive Sotorasib orally QD or adagrasib orally twice a day (BID)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Divarasib
2021
Completed Phase 1
~430
Find a Location
Who is running the clinical trial?
Chugai PharmaceuticalIndustry Sponsor
98 Previous Clinical Trials
22,268 Total Patients Enrolled
Hoffmann-La RocheLead Sponsor
2,463 Previous Clinical Trials
1,102,807 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,233 Previous Clinical Trials
901,917 Total Patients Enrolled